Randomized Controlled Trial- Ablation Strategy for Paroxysmal Atrial Fibrillation - Trigger and Substrate Guided Wide Area Radiofrequency Ablation Compared to Pulsed Field Ablation Pulmonary Vein Isolation

NCT04823299 | Recruiting DMC

• 1 other identifier: v21022021
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 2

Brief Summary

Atrial fibrillation (AF) is a common heart rhythm disorder affecting over a million people in North America and is associated with serious complications including stroke, heart failure, reduced quality of life, and premature death. Catheter ablation has been shown to be more effective than medications for controlling symptoms and reducing the risk of these complications; however, recurrence of AF after ablation remains a significant challenge, often due to incomplete or ineffective initial procedures. This clinical trial aims to determine whether a novel, patient-tailored ablation strategy can improve outcomes compared to the current standard-of-care approach. Participants will be randomly assigned to undergo either standard pulmonary vein isolation or a more individualized ablation procedure that identifies and targets patient-specific sources of AF. All participants will undergo the ablation procedure, receive continuous heart rhythm monitoring, and be followed over time to assess recurrence and safety outcomes.

Conditions

Atrial Fibrillation; Catheter Ablation; Radiofrequency Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial fibrillation, atrial flutter or atrial tachycardia

  AF, AFl or AT, symptomatic or asymptomatic lasting ≥ 30 seconds

  61 to 730 days after ablation

Secondary Outcomes (16)

• Atrial fibrillation burden

  730 days

• Long-term rate of documented atrial fibrillation, atrial flutter or atrial tachycardia

  730 days

• Incidence of any ECG/ILR documented atrial fibrillation, atrial flutter or atrial tachycardia

  First 60 days after catheter ablation

• Ablation procedure duration

  On day of ablation

• Fluoroscopic exposure

  On day of ablation

Study Arms (2)

PVI-ONLY ablation

ACTIVE COMPARATOR

Pulsed Field Ablation (PFA), control arm

Procedure: PVI-ONLY, CONTROL ARM

PVI-PLUS ablation

EXPERIMENTAL

RADIOFREQUENCY CATHETER ABLATION (RFA), interventional arm

Procedure: PVI-PLUS ARM, INTERVENTIONAL ARM

Interventions

PVI-ONLY, CONTROL ARM PROCEDURE

PULSED FIELD ABLATION (PFA) PVI-ONLY STRATEGY: CONTROL ARM

PVI-ONLY ablation

PVI-PLUS ARM, INTERVENTIONAL ARM PROCEDURE

RADIOFREQUENCY CATHETER ABLATION (RFA) PVI-PLUS : INTERVENTION ARM

PVI-PLUS ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years on the date of consent for the trial.
• Subjects must have paroxysmal AF with at least one episode of AF over the past 12 months (patients on antiarrhythmic medications do not need to satisfy this criterion).
• At least one episode of AF documented on 12-lead ECG, Holter monitor, Trans-telephonic monitor (TTM) or Loop Recorder.
• Subjects must be able to provide informed consent.

You may not qualify if:

• Persistent and permanent AF.
• History of previous catheter or surgical ablation for AF, AFl, AT, Atrioventricular Nodal Reentrant Tachycardia (AVNRT), Atrioventricular Reentrant Tachycardia (AVRT).
• Documented AVNRT, AVRT, AT or Atrial Flutter prior to enrolment in the trial.
• Previous left atrial (LA) ablation or LA surgery.
• Previous pulmonary vein stenosis or pulmonary vein stent.
• Pre-existing hemi-diaphragmatic paralysis.
• Active intracardiac thrombus.
• Contraindication to systemic oral anticoagulation therapy
• Current immunosuppressant therapy (corticosteroids, biologic immunomodulators; such patients may be considered if they can safely discontinue immunosuppressants for three months prior to and for three months following catheter ablation).
• Reversible causes of AF (e.g., uncontrolled hyperthyroidism, within six months of cardiac surgery).
• Left ventricular ejection fraction \<35%.
• NYHA Class 4 heart failure.
• Hypertrophic cardiomyopathy
• Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation).
• Patients with mechanical mitral prosthetic valves

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Abbott: collaborator

Study Sites (2)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Girish Nair, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Girish Nair, MD

CONTACT

613-696-7272; GNair@ottawaheart.ca

Sonya Jancar

CONTACT

613-696-7000; sjancar@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant only blinded to the treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind, prospective, randomized

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 30, 2021
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2025-07

Locations

CA (2)